Predictors of Persistence of Use of the Novel Antidiabetic Agent Acarbose

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Abstract
ACARBOSE IN THE first of a new class of oral antidiabetic agents (the α-glucosidase inhibitors). The clinical practice guidelines of the Canadian Diabetes Association1 recommend acarbose for the treatment of type 2 diabetes mellitus as monotherapy (in addition to dietary modification) or as add-on therapy for patients who are not well controlled with other oral antidiabetic agents (metformin and sulfonylureas) or insulin. Gastrointestinal adverse effects are noted as a possible limiting factor.1 Although the efficacy and safety of acarbose in hyperglycemic control have been well demonstrated,2-4 approximately 50% or more of acarbose-treated participants in recent clinical trials5-9 reported adverse gastrointestinal effects. Such effects arise by virtue of the mechanism of action of acarbose, whereby the absorption of carbohydrates from the intestine is delayed,10 providing a substrate for fermentation by colonic flora.11 Although these effects are not serious and are known to diminish over time,9 patients in general clinical practice may not be adequately informed of this fact or as motivated as trial participants to persist with the therapy and hence may prematurely discontinue use of the agent. In 4 recent randomized clinical trials5-7,9 on the use of acarbose as a first-line antidiabetic agent, the proportion of randomized participants who did not complete the trials varied from 2% to 29% (mean [SD], 14.8% [11.0%]). In the recent United Kingdom Prospective Diabetes Study,4 in which preexisting therapies of participants included diet alone (14%), monotherapy (52%), and combination therapy (34%), 58% of participants assigned to the acarbose group (vs 39% assigned to the placebo group) discontinued treatment after 3 years, with the significantly lower compliance rate for the acarbose group being primarily related to the higher proportion of patients reporting flatulence and diarrhea. However, drug discontinuation is typically substantially higher in primary care settings than in randomized clinical trials.12